Provisional Translation
| OTO No. | 274 | Classification | MHW-150 |
|---|---|---|---|
| Date of Acceptance | June 12, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | Concerning import approval for cardiac pacemakers, 1. One request is made for all of the data needed for evaluation and processing. 2. Permission substituting single-chamber data or foreign-generated data for dual-chamber data. |
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| Details of Measures | 1. It was replied that the officials concerned would continue to make bulk request for the data as specified in the Guide to Medical Device Registration in Japan and Ministry of Health and Welfare Notification No. 101 standards for cardiac pacemakers. 2. (1)Regarding clinical test data, it was replied that the need to ascertain effectiveness and safety preclude the substitution of single-chamber data for dual-chamber data. (2)However, it was also replied that, since Japan is basically amenable to accepting foreign-generated data, it should be possible for foreign-generated dual-chamber data to be accepted if it is attached to the application and meets the standards. |
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| Classification of Processing | 1. Cc 2. (1) D, (2) Ca |
Directions | 1. II-a 2. (1) II-a, (2) II-b |
| Remarks | |||